Carcinoma, HepatocellularNCT03191123
Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma With Solitary Huge Tumor
A study testing hepatic resection and TACE in people with Carcinoma, Hepatocellular and Survival Rate, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
This clinical trial aims to compare hepatectomy with Transarterial Chemoembolization (TACE) for Hepatic Cellular Cancer With Solitary Huge Tumor (≥5cm). All patients will be divided into two group.One group will receive hepatic resection, while an another equivalent group patients will be treated with Transarterial… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Carcinoma, Hepatocellular, Survival Rate
- What is being tested?
- hepatic resection and TACE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2016to 5 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Hepatic cellular Carcinoma.
- Patients with Solitary Huge Tumor (≥5cm）of Hepatic cellular Carcinoma (HCC) detected by Serum Alpha Fetoprotein (AFP) and CT or MRI.
- Patients without Hepatic vein or bile duct invasion and extrahepatic metastasis.
- Patients without surgical contraindication.
- Patients with Child A or B liver function and indocyanine green retention rate at 15min (ICGR15) < 10% before treatment.
- Laboratory examination: haemoglobin (Hb)>100g/L, white blood cell (WBC) > 3000/mL, blood platelet counts (PLT) > 8×10*10/L before treatment.
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- Patients without severe esophagogastric varices before treatment.
- Patients with HBV，HBV DNA≤100, 000 copy/mL.
- All of the patients has written consent for this research.
Who cannot join
- Patients with multiple tumors or vascular or bile duct invasion or extrahepatic metastasis.
- Patients with surgical contraindication.
- Patients with Child C grade liver function before treatment.
- Patients with other malignancy.
- .Patients treated with hepatic resection or TACE before this treatment.
- Patients with severe esophagogastric varices or refractory ascites or coagulation dysfunction before treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hepatic surgery center, Tong ji Hospital
Wuhan, Hubei, 430030
Xiaoping Chen, Doctor, 8602783662851, chenxp@medmail.com.cn
Ganxun Li, Doctor, 8615271899935, liganxun@hust.edu.cn
About this study
Official title: Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma With Solitary Huge Tumor: a Randomized Controlled Trial
This clinical trial aims to compare hepatectomy with Transarterial Chemoembolization (TACE) for Hepatic Cellular Cancer With Solitary Huge Tumor (≥5cm). All patients will be divided into two group.One group will receive hepatic resection, while an another equivalent group patients will be treated with Transarterial Chemoembolization.
Read the detailed description
Hepatocellular carcinoma (HCC) is the most common primary malignant tumor of the liver.For Barcelona Clinic Liver Cancer (BCLC) stage B patients，especially those with Solitary Huge Tumor (≥5cm) ，the better therapy between hepatic resection and transarterial chemoembolization remains controversial despite extensive studies。 From now on, we prospectively collected patients with solitary huge HCC who received hepatectomy or TACE. Of the 200 patients，100 patients were surgically treated and the others underwent TACE。After the treatment, patients received routine follow-up with physical examination, serum α-fetoprotein (AFP) level and ultrasonography at 3-month intervals for the first year and then every 6 months.The end of follow-up was determined as either the time of last follow-up (July 2019) or death. The overall survival，including 1, 2 and 3-year overall survival rates，will be analyse. All data are collected prospectively.
- Conditions
- Carcinoma, Hepatocellular, Survival Rate
- Being tested
- hepatic resection, TACE
- Keywords
- Hepatocellular Carcinoma, Hepatic Resection, TACE, Solitary Huge Tumor, Overall Survival
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatic resectionProcedure or surgery
Also called control
The aim of this intervention is to reach curative resection.
TACEProcedure or surgery
Also called trial
The aim of this intervention is one of the palliative treatment.
| Study group | Role | What they receive |
|---|---|---|
| Hepatic resection | Active comparator | Indications for Hepatic resection were the presence of appropriate residual liver volume determined by volumetric computed tomography and lack of hepatic encephalopathy. Receives: Procedure: hepatic resection |
| Transarterial Chemoembolization(TACE) | Experimental | Transarterial Chemoembolization is performed in less than one week after clinical diagnosis. Receives: Procedure: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year overall survival
Overall survival rate will be evaluated at 3 years after treatment
Measured: 3 years
Secondary outcomes (3)
1-year overall survival
Overall survival rate will be evaluated at 1 year after treatment
Measured: 1 years
2-year overall survival
Overall survival rate will be evaluated at 2 years after treatment
Measured: 2 years
Recurrence rates
any recurrence detected by CT, MRI and laboratory examination
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start5 Jul 2016
- Primary completion5 Jul 2018 (estimated)
- Study completion5 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoping Chen, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191123
- Sponsor's protocol ID
- chenxp008
- Status last verified
- Apr 2018
- First submitted
- 14 Jun 2017
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yin L, Li H, Li AJ, Lau WY, Pan ZY, Lai EC, Wu MC, Zhou WP. Partial hepatectomy vs. transcatheter arterial chemoembolization for resectable multiple hepatocellular carcinoma beyond Milan Criteria: a RCT. J Hepatol. 2014 Jul;61(1):82-8. doi: 10.1016/j.jhep.2014.03.012. Epub 2014 Mar 17.
PubMed 24650695Metussin A, Patanwala I, Cross TJ. Partial hepatectomy vs. transcatheter arterial chemoembolization for resectable multiple hepatocellular carcinoma beyond Milan criteria: a RCT. J Hepatol. 2015 Mar;62(3):747-8. doi: 10.1016/j.jhep.2014.08.057. Epub 2014 Nov 7. No abstract available.
PubMed 25450210Jin YJ, Lee JW, Choi YJ, Chung HJ, Kim YS, Lee KY, Ahn SI, Shin WY, Cho SG, Jeon YS. Surgery versus transarterial chemoembolization for solitary large hepatocellular carcinoma of BCLC stage A. J Gastrointest Surg. 2014 Mar;18(3):555-61. doi: 10.1007/s11605-013-2440-x. Epub 2014 Jan 14.
PubMed 24420729
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma With Solitary Huge Tumor: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03191123
- Acronym / sponsor ID
- chenxp008
- Conditions
- Carcinoma, Hepatocellular, Survival Rate
- Keywords
- Hepatocellular Carcinoma, Hepatic Resection, TACE, Solitary Huge Tumor, Overall Survival
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 5 Jul 2016 (actual)
- Primary completion
- 5 Jul 2018 (estimated)
- Study completion
- 5 Jul 2019 (estimated)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial aims to compare hepatectomy with Transarterial Chemoembolization (TACE) for Hepatic Cellular Cancer With Solitary Huge Tumor (≥5cm). All patients will be divided into two group.One group will receive hepatic resection, while an another equivalent group patients will be treated with Transarterial Chemoembolization.
Detailed description
Hepatocellular carcinoma (HCC) is the most common primary malignant tumor of the liver.For Barcelona Clinic Liver Cancer (BCLC) stage B patients，especially those with Solitary Huge Tumor (≥5cm) ，the better therapy between hepatic resection and transarterial chemoembolization remains controversial despite extensive studies。 From now on, we prospectively collected patients with solitary huge HCC who received hepatectomy or TACE. Of the 200 patients，100 patients were surgically treated and the others underwent TACE。After the treatment, patients received routine follow-up with physical examination, serum α-fetoprotein (AFP) level and ultrasonography at 3-month intervals for the first year and then every 6 months.The end of follow-up was determined as either the time of last follow-up (July 2019) or death. The overall survival，including 1, 2 and 3-year overall survival rates，will be analyse. All data are collected prospectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hepatic resection | Active comparator | Procedure: hepatic resectionIndications for Hepatic resection were the presence of appropriate residual liver volume determined by volumetric computed tomography and lack of hepatic encephalopathy. |
| Transarterial Chemoembolization(TACE) | Experimental | Procedure: TACETransarterial Chemoembolization is performed in less than one week after clinical diagnosis. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinical diagnosis of Hepatic cellular Carcinoma.
- Patients with Solitary Huge Tumor (≥5cm）of Hepatic cellular Carcinoma (HCC) detected by Serum Alpha Fetoprotein (AFP) and CT or MRI.
- Patients without Hepatic vein or bile duct invasion and extrahepatic metastasis.
- Patients without surgical contraindication.
- Patients with Child A or B liver function and indocyanine green retention rate at 15min (ICGR15) < 10% before treatment.
Key exclusion criteria (6 listed)
- Patients with multiple tumors or vascular or bile duct invasion or extrahepatic metastasis.
- Patients with surgical contraindication.
- Patients with Child C grade liver function before treatment.
- Patients with other malignancy.
- .Patients treated with hepatic resection or TACE before this treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hepatic resectionAlso: controlThe aim of this intervention is to reach curative resection. | Procedure or surgery | Hepatic resection |
| TACEAlso: trialThe aim of this intervention is one of the palliative treatment. | Procedure or surgery | Transarterial Chemoembolization(TACE) |
Primary outcome
3-year overall survival
Time frame: 3 years
Overall survival rate will be evaluated at 3 years after treatment
3 secondary outcomes
1-year overall survival
Time frame: 1 years
2-year overall survival
Time frame: 2 years
Recurrence rates
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
- Results publication: PubMed 24650695Yin L, Li H, Li AJ, Lau WY, Pan ZY, Lai EC, Wu MC, Zhou WP. Partial hepatectomy vs. transcatheter arterial chemoembolization for resectable multiple hepatocellular carcinoma beyond Milan Criteria: a RCT. J Hepatol. 2014 Jul;61(1):82-8. doi: 10.1016/j.jhep.2014.03.012. Epub 2014 Mar 17.
- Results publication: PubMed 25450210Metussin A, Patanwala I, Cross TJ. Partial hepatectomy vs. transcatheter arterial chemoembolization for resectable multiple hepatocellular carcinoma beyond Milan criteria: a RCT. J Hepatol. 2015 Mar;62(3):747-8. doi: 10.1016/j.jhep.2014.08.057. Epub 2014 Nov 7. No abstract available.
- Results publication: PubMed 24420729Jin YJ, Lee JW, Choi YJ, Chung HJ, Kim YS, Lee KY, Ahn SI, Shin WY, Cho SG, Jeon YS. Surgery versus transarterial chemoembolization for solitary large hepatocellular carcinoma of BCLC stage A. J Gastrointest Surg. 2014 Mar;18(3):555-61. doi: 10.1007/s11605-013-2440-x. Epub 2014 Jan 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hepatic resection and TACE in people with Carcinoma, Hepatocellular and Survival Rate, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ganxun Li, Doctor (+8615271899935, liganxun@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year overall survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03191123, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2018.